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Completed

NCT Number: NCT03329638

A Study Assessing the Efficacy and Safety of DE-127 Ophthalmic Solution in Subjects With Mild or Moderate Myopia (APPLE)

To investigate the safety and efficacy of three concentrations of DE-127 ophthalmic solution when compared to Placebo in subjects diagnosed with mild or moderate myopia.

To investigate the dose response of DE-127.

Completed

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Singapore National Eye Centre

Singapore

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Refractive error of spherical equivalent -1.0 diopter to -6.0 diopter in both eyes
  • Anisometropia of spherical equivalent less than or equal to 1.50 diopter in both eyes
  • Distance vision correctable to logMAR 0.2 or better in both eyes
  • Normal intraocular pressure of not greater than 21 mmHg in both eyes
  • No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride

Exclusion criteria

  • Amblyopia or manifest strabismus including intermittent tropia
  • Ocular disorders that potentially affect myopia or refractive power
  • Previous or current use of contact lenses, bifocal lenses, progressive addition lenses, or other forms of treatment (including atropine and pirenzepine) for myopia
  • Systemic disorders that potentially affect myopia or refractive power

Treatment and study plan

DE-127 Ophthalmic Solution low dose

Drug

Low dose of DE-127 Ophthalmic Solution dosed once daily for 12 months

DE-127 Ophthalmic Solution medium dose

Drug

Medium dose of DE-127 Ophthalmic Solution dosed once daily for 12 months

DE-127 Ophthalmic Solution high dose

Drug

High dose of DE-127 Ophthalmic Solution dosed once daily for 12 months

Placebo Ophthalmic Solution

Drug

Placebo Ophthalmic Solution dosed once daily for 12 months

Primary outcomes

  1. Spherical equivalent

    Time frame: Month 12

    Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at Month 12 in the study eye.

Sponsors and collaborators

Lead sponsor

Santen Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase II, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study Assessing the Efficacy and Safety of DE-127 Ophthalmic Solution Compared With Placebo in Subjects With Mild or Moderate Myopia (APPLE)

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Nov 6, 2017
Registry last updated
Aug 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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